Antireflux Ablation of the Cardia Mucosa vs Placebo for the Treatment of Gastroesophageal Reflux Disease

April 22, 2025 updated by: Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Double-blind, Placebo-controlled Clinical Trial on the Efficacy of Antireflux Ablation of the Cardiac Mucosa for the Treatment of Gastroesophageal Reflux Disease

The ARMA technique improves GORD-related quality of life with a low proportion of adverse effects.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Gastroesophageal reflux disease (GERD) is defined as the presence of symptoms or complications secondary to the passage of gastric contents into the esophagus, oral cavity or structures of the airway. The prevalence worldwide is between 8-33%. The clinical practice guidelines of the American College of Gastroenterology establish that first-line treatment, in the absence of alarm symptoms, should be carried out empirically. This treatment consists of hygienic-dietary measures and the use of proton pump inhibitors (PPIs) for 8-12 weeks. Despite the proven effectiveness of PPIs, there is 10-40% of patients who do not respond adequately to this treatment. All this has motivated the appearance of endoscopic and surgical techniques that offer an alternative to medical treatment. Among them is the technique of antireflux ablation of the cardiac mucosa (ARMA) in which the resection of the mucosa is replaced by an ablation with electrocoagulation current or by argon gas fulguration.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
64

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Enrique MD Rodríguez de Santiago
  • Phone Number: +34913668772
  • Email: enrodesan@gmail.com

Study Contact Backup

Study Locations

  • Spain
      • Avilés, Spain
        • Hospital de San Agustín
      • Badalona, Spain
        • Hospital Germans Trías i Pujol
      • Barcelona, Spain
        • Hospital Del Mar
      • Gijón, Spain
        • Hospital de Cabueñes
      • Madrid, Spain
        • Hospital 12 de Octubre
      • Madrid, Spain
        • Hospital La Paz
      • Pamplona, Spain
        • Complejo Hospitalario de Navarra
      • Valencia, Spain
        • Hospital La Fe
      • Valladolid, Spain
        • Hospital Rio Hortega

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age over 18 years.
  2. GERD symptoms lasting more than 6 months, not necessarily consecutive. They should at least have a typical GERD symptom (heartburn or regurgitation).
  3. Total acid exposure time> 6% in pH measurement study without PPI treatment.
  4. Patients who do not want to take PPIs or with chronic consumption, defined as PPI consumption of more than 6 months (consecutive or not) in the last 2 years.
  5. Response to PPI treatment, defined as an increase of> 10 points on the GERD-HRQL questionnaire 15 days after discontinuation of the PPI.
  6. Written informed consent to participate in the study.

Exclusion Criteria:

  1. Patients with sliding hiatal hernia> 2 cm.
  2. Presence of only atypical GERD symptoms.
  3. Age> 75 years.
  4. Grade D peptic esophagitis.
  5. Body mass index> 35 40 kg / m2.
  6. Liver cirrhosis.
  7. Pregnancy.
  8. Incomplete relaxation of the LES in MAR (PIR> 15 mmHg).
  9. Absent peristalsis, defined as 100% failed waves with DCI <100 mmHg * cm * s in MAR.
  10. Esophagogastric surgery or previous endoscopic antireflux technique.
  11. Barrett's esophagus with dysplasia.
  12. Oncological disease.
  13. Esophageal strictures or ulcers.
  14. Severe cardiopulmonary comorbidity (ASA functional class IV-V).
  15. Previously known coagulopathy.
  16. Severe psychiatric disorder
  17. Refusal to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: (ARMA) antireflux ablation of the cardiac mucosa
The ARMA (Ablation with electrocoagulation current or by argon gas fulguration) technique will be performed in patients assigned to this treatment arm.
Procedure: ARMA (antireflux ablation of the cardiac mucosa)
is an endoscopy in which argon gas ablation of the cardiac mucosa
Placebo Comparator: upper digestive endoscopy
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.
Procedure: upper digestive endoscopy
Quality diagnostic upper gastrointestinal endoscopy will be performed without intervention in patients assigned to this treatment arm.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
To evaluate the clinical efficacy (measured through the GERD-HRQL questionnaire) of the ARMA technique for the endoscopic treatment of PPI-dependent GERD.
Time Frame: The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
GERD-HRQL questionnaire score. Quantitative variable. Clinical success will be defined as a> 50% reduction in symptom score. The scale has 11 items. Each item is scored from 0 to 5, with a higher score indicating a better QOL.
The GERD-HRQL questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
GERD-Q questionnaire score
Time Frame: The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
The GERDQ questionnaire is diagnostic for gastroesophageal reflux disease. Clinical success will be defined as a> 50% reduction in symptom score. The total Total score of 0 to 2 points = 0 % likelihood of GERD; 3 to 7 points = 50 %; 8 to 10 points = 79 %; 1 to 18 points = 89%;
The GERD-Q questionnaire score without PPI from visit 1 will be compared with the score without PPI from visit 4 (month 12).
PPI consumption
Time Frame: It is measured in the different visits after the intervention (month 1, month 3 and month 12)
Ordinal qualitative variable: The patient will indicate if he feels satisfied / neutral / dissatisfied.
It is measured in the different visits after the intervention (month 1, month 3 and month 12)
pHmetry-impedancemetry
Time Frame: This test will be performed on the patient before the intervention, in month 3 and in month 12
Technique used to quantify acid, know when there is more acid reflux and correlate symptoms with the presence of that acid. one of the measurements that we are going to obtain with this test is acid exposure time.
This test will be performed on the patient before the intervention, in month 3 and in month 12
High resolution manometry
Time Frame: This test will be performed on the patient before the intervention, in month 3 and in month 12
This technique measures the pressure of esophageal contractions and with this technique different measurements are obtained such as lower esophageal sphincter resting pressure, integrated relaxation pressure, ICD.
This test will be performed on the patient before the intervention, in month 3 and in month 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Spanish Society of Digestive Endoscopy

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Enrique MD Rodríguez de Santiago, Servicio de Gastroenterología y Hepatología Hospital Ramón y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
February 7, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 21, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 13, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 15, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 22, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • ECA-HRC-ARMA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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